Ashton and Parsons Teething Powders

A traditional herbal medicinal product used for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling based on traditional use only.

For oral short term use only.

Method of administration: Oral use whilst the infant is held in a sitting or upright position. Put the powder slowly on the front of the infant's tongue, a little at a time, allowing the powder to fully dissolve.

This product is only intended for use in teething infants.

This product is not recommended for use in infants under 3 months old.

If symptoms worsen or persist after 7 days of using this product, a doctor or qualified healthcare practitioner should be consulted.

Hypersensitivity to the active substance, any members of the Asteraceae/ Compositae family or to any of the excipients.

Matricaria may precipitate an allergic reaction or exacerbate existing symptoms in susceptible individuals (e.g. asthmatics).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

None known.

The use of this product in pregnancy and lactation is not applicable.

Studies on the effects on fertility have not been performed.

None known.

Hypersensitivity reactions including urticaria, contact sensitivity, rash; application site reactions including lesions (tongue).

The frequency is not known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Overdosage with this product would cause diarrhoea due to excessive lactose intake.

Treatment would be by withdrawal of the product and supportive measures such as oral rehydration therapy.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Tests on reproductive toxicity and carcinogenicity have not been performed.

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537 and E.Coli strain WP2 uvrA) mutation assay with or without metabolic activation.

Lactose.

None stated.

36 months unopened.

Store below 25° C

The powder is contained in a paper/PE/Al foil/PE laminate sachet. 10, 20 or 30 sachets are packed in a boxboard carton.

Not all pack sizes may be marketed.

No special requirements.